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Diomed 25 25W Surgical Diode Laser

by Dio-Med Corp. 3 variants

510(k) K931776

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931776 Date19 Oct 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Diomed 25 25W Surgical Diode Laser is a powered laser surgical instrument designed for medical use. As classified under FDA regulation 878.4810, it falls under the category of diode lasers, which emit coherent light for precise tissue interaction. This device is intended for surgical applications, including general, plastic, gynecological, and urological procedures, where controlled laser energy is required. Its specifications indicate a power output of 25 watts, enabling effective cutting, coagulation, or vaporisation of tissue.

The Diomed 25 25W Surgical Diode Laser is supplied as a reusable medical device and is intended for use in sterile surgical environments. It is regulated under FDA 510(k) clearance (K931776) and falls under the GEX product code, with a decision of Substantially Equivalent (SESE) by the Surgical Devices Panel. The device was originally submitted in 1993 and remains compliant with existing regulatory standards. No specific MRI safety classification or single-use designation is noted in the available data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What surgical procedures is the Diomed 25 25W Surgical Diode Laser designed for?

    The Diomed 25 25W Surgical Diode Laser is intended for controlled laser energy applications in general, plastic, gynecological, and urological surgeries. Its 25-watt power output allows for precise tissue interaction, including cutting, coagulation, or vaporisation, where laser precision is critical.

  • Is the Diomed 25 25W Surgical Diode Laser a single-use or reusable device?

    The Diomed 25 25W Surgical Diode Laser is designed as a reusable medical device. It must be used in sterile surgical environments to maintain safety and efficacy, requiring proper cleaning and sterilisation between procedures.

  • What is the power output of the Diomed 25 25W Surgical Diode Laser, and how does it affect its use?

    The device delivers a consistent 25-watt power output, enabling effective tissue manipulation for cutting, coagulation, or vaporisation. This power level is suitable for a range of surgical applications where controlled laser energy is required, balancing precision with clinical versatility.

  • What regulatory clearance does the Diomed 25 25W Surgical Diode Laser hold, and when was it approved?

    The Diomed 25 25W Surgical Diode Laser holds FDA 510(k) clearance under the product code GEX, with a decision of Substantially Equivalent (SESE) by the Surgical Devices Panel. It was originally submitted in 1993 and remains compliant with existing regulatory standards.

  • Does the Diomed 25 25W Surgical Diode Laser have any specific MRI safety classification?

    The available data does not specify an MRI safety classification for the Diomed 25 25W Surgical Diode Laser. Clinicians should verify compatibility with their facility’s MRI protocols before use in environments where MRI scans are performed.